A Study Evaluating Daily Oral Doses of TLC-3595 in Participants With Insulin Resistance

NCT05665751 | Active Not Recruiting Phase 2

• 1 other identifier: 3595-CL-101
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 4

Brief Summary

This Phase 2a study is designed to evaluate the safety, tolerability, effectiveness, and pharmacokinetics (PK) of TLC-3595 in subjects with insulin resistance.

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (2)

• Change in insulin sensitivity

  Oral glucose tolerance test will be used to measure insulin sensitivity.

  Through study completion, up to Day 84 of the study

• Incidence of TLC-3595 treatment-emergent adverse events

  Adverse events (AEs) - severity of the AEs will be graded using the Common Terminology Criteria for AE (CTCAE) (v5.0). The relationship between AEs and the study drug will be indicated as related or not related.

  Through study completion, up to Day 84 of the study

Study Arms (3)

TLC-3595 Dose 1

EXPERIMENTAL

Oral dose of TLC-3595 Dose 1

Drug: TLC-3595 Dose 1

TLC-3595 Dose 2

EXPERIMENTAL

Oral dose of TLC-3595 Dose 2

Drug: TLC-3595 Dose 2

Placebo

PLACEBO COMPARATOR

Oral dose of placebo-to-match

Drug: Placebo

Interventions

TLC-3595 Dose 1 DRUG

Tablets administered orally

TLC-3595 Dose 1

TLC-3595 Dose 2 DRUG

Tablets administered orally

TLC-3595 Dose 2

Placebo DRUG

Tablets administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between 18-70 years of age, inclusive, at Screening
• BMI ≥ 28 kg/m2 at Screening
• Diagnosis of insulin resistance based on HOMA-IR \> 2.84 at Screening or a confirmed diagnosis of type 2 diabetes mellitus
• Screening laboratory evaluations (hematology, chemistry, and urinalysis) must fall within the protocol-defined ranges
• A 12-lead electrocardiogram (ECG) at Screening that is normal or with abnormalities that are considered not clinically significant by the investigator
• Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to first dose of study drug
• Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

You may not qualify if:

• HbA1c \> 10% at Screening
• Weight loss \> 5% weight during the 90 days prior to Screening
• Pregnant or lactating subjects.
• Current alcohol abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety
• Current substance abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety
• A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen, or hepatitis C (HCV) antibody
• Unstable cardiovascular disease as defined by any of the following: unstable angina within 6 months prior to Screening; myocardial infarction, coronary artery bypass graft surgery, or coronary angioplasty within 6 months prior to Screening; transient ischemic attack or cerebrovascular accident within 6 months prior to Screening; obstructive valvular heart disease or hypertrophic cardiomyopathy; congestive heart failure (NYHA Class ≥ 2); implanted defibrillator or pacemaker
• Medical history of liver disease, including but not limited to, alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency. A history of nonalcoholic fatty liver disease (NAFLD), including hepatic steatosis or nonalcoholic steatohepatitis (NASH) is permitted.
• History of intestinal resection or malabsorptive condition that may limit the absorption of study drug
• Presence of severe peptic ulcer, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions at Screening, in the opinion of the investigator
• Any scheduled surgery during the trial period, excluding minor surgical procedures performed under local anesthesia, in the opinion of the investigator
• History of malignancy within 5 years prior to Screening except adequately treated carcinoma in situ of the cervix, and/or squamous cell cancer, or other localized non-melanoma skin cancer
• History of significant drug allergy, such as anaphylaxis or significant drug sensitivity, in the opinion of the investigator
• Known hypersensitivity to study drug, its metabolites, or formulation excipients
• Presence of any medical condition that could, in the opinion of the investigator, compromise the subject's ability to participate in the study, including a history of substance abuse or a psychiatric disorder, including any subject with a psychiatric hospital admission or emergency room visit in the 2 years prior to Screening

Sponsors & Collaborators

• OrsoBio, Inc: lead

Study Sites (4)

OrsoBio Research Site

Auckland, 0626, New Zealand

Location

OrsoBio Reseach Site

Auckland, 1010, New Zealand

Location

OrsoBio Research Site

Auckland, 1010, New Zealand

Location

OrsoBio Research Site

Christchurch, 8011, New Zealand

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• OrsoBio Study Director

  OrsoBio, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: December 27, 2022
• Study Start: March 8, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

NZ (4)